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临床试验/NCT05330091
NCT05330091Unknown不适用

Garden of Life Once Daily Women's Probiotic: Vaginal pH and Quality of Life Study

Garden of Life, LLC1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年2月9日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Vaginal pH

研究概览

简要总结

This decentralized observational study is designed to understand the effects of daily consumption of once daily woman's probiotic (ODWP) on vaginal pH levels in healthy female populations ages 19-70 years of age across the United States.

详细描述

This decentralized observational study is designed to understand the effects of daily consumption of once daily woman's probiotic (ODWP) on vaginal pH levels in healthy female populations ages 19-70 years of age across the United States. Participants will be divided into two cohorts of 100 participants each; one with a history of vaginal bacteriosis and one with no history of bacterial vaginosis, with between 20-30 percent of the total participants being post-menopausal. Participants will be provided and trained to use pH tests on a daily basis over the course of four menstrual cycles (or equivalent time for amenorrheic participants). During the first cycle (or equivalent timeframe) of measurement, participants will not consume neither placebo or once daily woman's probiotics (ODWP); allowing the establishment of a baseline or wash out period prior to active consumption and measurement of effect.

Participants will receive ODWP at no charge for consumption over the course of the study. Participants will be instructed to start and continue consumption over three menstrual cycles (or equivalent timeframe) based on participant's menstrual status and her demonstrated ability to self-measure and report vaginal pH via the Validcare Study app based platform (aka "the app), which is provided as a free, downloadable 21 CFR Part 11 compliant interface for all patient facing activities and communication with/from the principal investigator for the study duration.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
19 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age: 19-70 (21-70 for residents of Mississippi)
  • Non-menopausal women must have a regular menstrual cycle (26-32 days)
  • Using birth control
  • Sexually active (intercourse at least 2x/month)
  • Agree to not introduce any other probiotic during the three months of study

排除标准

  • OCP or systemic hormonal contraception
  • No antibiotic treatment for at least 30 days
  • No active vaginal infection or symptoms of infection
  • No probiotic use for 30 days
  • Routine douching (except for immediately after menses)

结局指标

主要结局

Vaginal pH

时间窗: 4 months

To compare the change in vaginal pH in both normal women and in normal women with a history of BV to and after treatment with Once Daily Women's Probiotic vs. placebo. Subjects will measure vaginal pH using a self-administered vaginal pH kit.

次要结局

未报告次要终点

研究者

发起方
Garden of Life, LLC
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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